Strattice Reconstructive Tissue Matrix 1025002Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M32810250020), received between Jul 23, 2021 and Jul 12, 2023 — classified as 2 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FOLLOW UP#1 TO REPORT ON (B)(6) 2023, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE PLAINTIFF PROFILE FORM WAS RECEIVED ASSOCIATED WITH THIS EVENT. AS PER THE PPF FORM, THE PATIENT UNDERWENT AN INCISIONAL HERNIA REPAIR AND WAS IMPLANTED WITH STRATTICE DEVICE LOT SP200140-135 ON (B)(6) 2019. THE PATIENT UNDERWENT ¿REPAIR OF RECURRENT INCISIONAL HERNIA WITH REMOVAL OF PREVIOUSLY PLACED MESH¿ AND WAS TREATED FOR ¿HERNIA RECURRENT¿ AND ¿PAIN" ON (B)(6) 2021. THE STRATTICE WAS EXPLANTED AND A NON-ABBVIE DEVICE, "COVIDIDEN¿ WAS IMPLANTED. NO OTHER INFORMATION WAS REPORTED. AS REPORTED IN THE INITIAL: LIMITED INFORMATION WAS REPORTED THROUGH A LEGAL EVENT THAT A PATIENT WAS IMPLANTED WITH STRATTICE FIRM ON (B)(6) 2019. THE FORM ALSO INDICATES THAT ON AN UNSPECIFIED DATE, THE STRATTICE IMPLANT HAD BEEN ¿REMOVED OR REVISED¿. NO INFORMATION WAS PROVIDED ON THE INDICATION FOR THE INITIAL SURGERY OR THE REASON FOR THE REMOVAL OR REVISION.

  Patient problems: Hernia

  MAUDE report 17310944 ↗
• InjuryJul 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HERNIA REPAIR SURGERY ON (B)(6) 2013, (B)(6) 2015, (B)(6)2016, (B)(6) 2017, (B)(6) 2017 AND (B)(6) 2018. THE PATIENT WAS A FEMALE BETWEEN THE AGES OF 38 AND 43 AT THE TIMES OF SURGERY. THE PATIENT WAS IMPLANTED WITH STRATTICE LOT SP100477-097 DURING THE (B)(6) 2017 PROCEDURE. THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2018 AND (B)(6) 2019. ON (B)(6) 2018, THE PATIENT HAD LYSIS OF ADHESIONS AND REMOVAL OF THE MESH AND A HERNIA REPAIR AT (B)(6). ON (B)(6) 2019 THE PATIENT HAD ANOTHER SURGERY REQUIRING ADDITIONAL REMOVAL OF THE STRATTICE MESH AT (B)(6). THIS RECORD IS FOR THE LOT SP100477-097 IMPLANTED (B)(6) 2017 (RECORD 5 OF 6).

  Patient problems: Hernia

  MAUDE report 12218213 ↗